Medicines that matter: Biohaven's Nurtec™ drug development journey

Migraine affects about 38 million U.S. adults and is described as the third most prevalent disease worldwide and seventh highest cause of disability, with attacks lasting 4-72 hours. Starting in 2017, more than 20 Certara scientists and regulatory experts partnered with Biohaven across clinical pharmacology, pharmacometrics, regulatory strategy, PBPK modeling, and medical affairs; notably, Simcyp PBPK modeling showed gastric pH did not significantly affect the drug's bioavailability, eliminating the need for a dedicated Phase I study. Certara also supported 9 published manuscripts plus 16 abstracts and posters. Nurtec received FDA approval for acute migraine treatment in February 2020, for migraine prevention in May 2021, and EU approval for both indications in April 2022, becoming the first and only CGRP receptor antagonist available as a fast-acting orally disintegrating tablet.

Certara is a biosimulation software company (Simcyp, Phoenix) whose PK/PD and QSP models predict drug behavior in the body; the FDA itself licenses Certara's software to review sponsor submissions.

This sits in the Build stage of the AI use-case lifecycle: Named examples from the foundation-model labs and platforms pharma teams use to actually construct, train and generate the model or application.